Sponsors no longer have to rely on checking lists of 510(k) devices when looking to make a substantial equivalence claim. While the FDA does release an updated list each month, Sponsors can save time by searching through a 510(k) database instead. The database enables Sponsors to search using a variety of criteria including product code, device name, and more.
Substantial Equivalence Definition
“Substantial equivalence means that the new device is at least as safe and effective as the predicate.” According to the FDA, a medical device is considered substantially equivalent if it has the same intended use and technological characteristics as the predicate device. If a medical device has the same intended use as the predicate device but different technological characteristics, it may still be considered substantially equivalent if the information submitted to the FDA:
- Does not raise new questions of safety and effectiveness; AND
- Demonstrates that the device is at least as safe and effective as the legally marketed device.
The FDA states that “a claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.”
Declaring Substantial Equivalence for a Medical Device
In order to demonstrate that a device is substantially equivalent to another medical device that is legally marketed in the US, a Sponsor must submit a 510(k) submission to the FDA. A 510(k) is a premarket submission with the purpose of demonstrating the medical device is as safe and effective to a legally marketed device. Sponsors are required to compare their medical device to one or more similar legally marketed devices in order to make substantial equivalence claims.
After a 510(k) has been submitted, the applicant may not market the device in question until it has received a letter from the FDA declaring the device substantially equivalent. The FDA may take up to 90 days to provide a substantial equivalence determination for medical devices.
As the Agency reviews applications, sometimes it determines that a device is not substantially equivalent. When this happens, the applicant has a few options, which include:
- Resubmit another 510(k) with new data
- Request a Class I or II designation through the de novo process
- File a classification petition
- Submit a premarket approval application (PMA)
FDA’s 510(k) Database and Device Lists
The 510(k) database makes it easy for Sponsors to search for devices, but lists are still being released around the 5th of each month. Sponsors can visit the downloadable files page on the FDA’s website to find devices from the most current month, along with historical data for 510(k) devices dating back to 1976.
Developing and submitting applications to the FDA can be a challenging task. If done incorrectly, it can cost huge sums of money and time – two things that many applicants can’t afford to waste. That is why we are here to help. We have a history of helping clients achieve successful interactions with FDA. To learn more about our services and how we can help you, contact us today.
